The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Modification To Elecsys Fsh Ii Calset.
| Device ID | K012399 |
| 510k Number | K012399 |
| Device Name: | MODIFICATION TO ELECSYS FSH II CALSET |
| Classification | Calibrator, Secondary |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 -0457 |
| Contact | Sherri L Coenen |
| Correspondent | Sherri L Coenen ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 -0457 |
| Product Code | JIT |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-27 |
| Decision Date | 2001-08-24 |
| Summary: | summary |